The Food and Drug Administration (FDA) has implemented a new policy regarding COVID-19 vaccine licenses. This policy prioritizes individuals over 65 and those with high-risk factors for severe COVID-19 outcomes. For these groups, the FDA will consider immunogenicity data (the vaccine's ability to generate antibodies) sufficient for approval.
However, for healthy individuals aged 6 months to 64 years without risk factors for severe COVID-19, the FDA will require randomized, controlled trial data demonstrating that the vaccine's benefits outweigh its risks before granting licenses for Biologics License Applications.
The impact of this policy on Pfizer, Moderna, and Novavax remains to be seen. These companies have not yet commented on the FDA's announcement.
The new policy âbalances competing values,â agency leaders said.
The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks, top agency officials said on May 20.
âFor all healthy personsâthose with no risk factors for severe Covid-19âbetween the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.â
Pfizer, Moderna, and Novavax, which have received licenses for their COVID-19 vaccines, did not immediately respond to requests for comment.
Makary and Prasad planned to talk about the policy update at 1 p.m. on Tuesday.
This is a developing story that will be updated.
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